TENS 7000 Combo

TENS TS1211 COMBO (Digital TENS & EMS)

Instruction Manual

INTRODUCTION
1.1 General Information:
This device is a lightweight and portable Combo TENS/EMS medical device. In TENS MODE, it
utilizes the low electric-current to stimulate muscle nerve to achieve the symptomatic relief of
chronic intractable pain, post-traumatic and post-surgical pain. In EMS MODE, it transmits
electrical pulses through the skin surface and stimulates motor units (nerve and muscles). The
electrical impulses are ramped so that they closely emulate natural muscle contractions. This
modality can help prevent disuse atrophy. Accordingly, incapacitated patients can receive
therapeutic treatment to create involuntary muscle contractions thereby improving and maintaining
muscle tone without actual physical activity.

1.2 Indications for Use:
TENS MODE is used in symptomatic relief of chronic intractable pain, post-traumatic and post-
surgical pain.

EMS MODE is intended to be used in:
Relaxation of muscle spasm.
Prevention or retardation of disuse atrophy.
Increase local blood circulation.
Muscle re-education.
Immediate post surgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.

1.3 Warnings:
1.3.1 The long-term effects of chronic electrical stimulation are unknown.
1.3.2 Stimulation should not be applied over the carotid sinus nerves, particularly in patients
with a known sensitivity to the carotid sinus reflex.
1.3.3 Stimulation should not be applied over the neck or mouth. Severe spasm of the laryngeal
and pharyngeal muscles may occur and the contractions may occur and the contractions
may be strong enough to close the airway or cause difficulty in breaching.
1.3.4 Stimulation should not be applied transthoracically introduction of electrical current into
the heart may cause cardiac arrhythmias.
1.3.5 Stimulation should not be applied over swollen, infected, or inflamed areas or skin
eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
1.3.6 Stimulation should not be applied over, or in proximity to, cancerous lesions.
1.3.7 For external use only.
1.3.8 Do not use this device on the eye area.
1.3.9 This device should be used only under the continued supervision of a physician.
1.3.10 Safety of devices for use during pregnancy or delivery has not been established.
1.3.11 Electronic equipment such as ECG monitors and ECG alarms may not operate properly
when device is in use.
1.3.12 Apply the electrodes to clean, dry and unbroken skin only.
1.3.13 This device should not be used while driving, operating machinery, or during any activity
in which involuntary muscle contractions may put the user at undue risk of injury.
1.3.14 This device should be kept out of the reach of children.

1.4 Precautions:
1.4.1 Caution should be used for patients with suspected or diagnosed heart problems.
1.4.2 Caution should be used for patients with suspected or diagnosed epilepsy.
1.4.3 Caution should be used in the presence of the following:
a. When there is a tendency to hemorrhage following acute trauma or fracture;
b. Following recent surgical procedures when muscle contraction may disrupt the healing
process.
c. Over the menstruating or pregnant uterus; and
d. Over areas of the skin which lack normal sensation.
1.4.4 Some patients may experience skin irritation of hypersensitivity due to the electrical
stimulation or electrical conductive medium. The irritation can usually be reduced by using
an alternate conductive medium, or alternate electrode placement.
1.4.5 Electrode placement and stimulation settings should be based on the guidance of the
prescribing practitioner.
1.4.6 This device should be used only with the leads and electrodes recommended for use by the
manufacturer.
1.4.7 Isolated cases of skin irritation may occur at the site of the electrode placement following
long-term application.
1.4.8 Effectiveness is highly dependent upon patient selection by a person qualified in the
management of pain patients.
1.4.9 If the stimulation levels are uncomfortable or become uncomfortable, reduce the
stimulation amplitude to a comfortable level and contact your physician if problems persist.

1.5 Adverse Reactions:
1.5.1 Possible skin irritation or electrode burn under the electrodes may occur.
1.5.2 Possible allergic skin reaction to tape or gel may occur.

Liver Cover:
A panel covers the controls for Mode, Set, Increase and Decrease adjusting. Your medical
professional may ask to set these controls for you and request that you leave the cover in place.

Amplitude Controls:
It controls the INTENSITY level of stimulating pulses. These controls located at the top of the
unit regulate the amplitude, or intensity of the stimulation and are the ON/OFF Control. The ON
indicator signal will stay lit as long as the unit is working, and mimics the output of the electrical
pulse.
Caution: If the stimulation levels are uncomfortable or become uncomfortable, reduce the
stimulation intensity to a comfortable level and contract your physician if problems persist.


Increase Control Button (using a triangle-button)
This button will carry on the increase character to increase the settings.

Decrease Control Button (using an inverted triangle-button)
This button will carry on the decrease character to decrease the settings.

Mode Button (using a round-button on the right side of the control panel)
This button will carry the character to select for a Stimulation-Mode.


Set Button (using a round-button on the middle of the control panel)
This button will carry the character to set the settings. Users press the SET button to enter a
parameter setting mode.

LCD Screen
This LCD will be utilized to display necessary information and to display timer. The channel
output will be indicated on the left side (Channel 1) and right side (Channel 2) of the LCD screen.
The modes will be showed on the top of the LCD panel. All the parameters of settings will be
showed on the middle-right of the screen one by one. The timer and clock symbol are showed on
the middle-left of the screen, the clock symbol will flash in final 5 min.

Battery Compartment
9 Voltage battery 1pc

STIMULATION MODES
The stimulation mode offers a variety of stimulation modes. The button is located under the front
lid cover and is adjusted by pressing on the MODE control button.
Be sure that when adjusting these stimulation modes, the intensity (Amplitude) output controls
should be set to the minimum output position first.
TENS
MODE Interpretations
Burst (B)
The burst mode provides a Burst of seven pulses. There are two
bursts that are delivered per second. Positive pulse and negative pulse
iterate continuously at fixed 100 Hz. Pulse width are adjustable from
50~300s.
Normal (N)
The Normal mode produces a continuous train of impulses. The
stimulation parameters are not automatically interrupted nor varied in
any way. In this mode, the pulse rate (from 2 to 150 Hz) and pulse
width (from 50 ~300s) are fully adjustable. The normal mode is quite
versatile because it may be applied with a variety of rate and width
settings.
Modulated Rate &
Width (MRW)
The pulse rate and width are automatically varied in a cycle to produce
a pleasant, massage-like sensation. Its believed that nerve can become
accustomed to, or accommodated to the same electrical stimulus after
a period of time and thus would require increasing the intensity to
further block the pain. The MRW mode was produced to offer a
variety of different electrical stimulating, thus preventing nerve
accommodation so that less intensity is required for long and effective
treatment. In this mode, during the beginning of 0.5 sec. period, the
WIDTH decrease to 50% of its original setting and then during the next
0.5 sec. period, the RATE is decrease to 50% of its original setting.
Therefore, the total cycle time is 1 second.
Strength
Duration(SD)
Strength-Duration modulation consists of alternating modulated
intensity and pulse width, so that the intensity is always increasing
while the pulse width is decreasing the vice-versa. The stimulation
intensity is modulated to 62.5% maximum of setting (width equal to
setting). The pulse width is modulated to 67% of setting (intensity equal
to setting). Total cycle time is 6 seconds. Pulse rate(from 2~150hz) and
pulse width(from 50~300s) are fully adjustable.
TENS
MODE Interpretations
Asymmetric (A)
The pulse of CHANNEL 1 and CHANNEL 2 are alternative. When
Channel 1 is activated, Channel 2 will be inactivated and vice versa.
In this mode, ON TIME value should be set for more than ramp up
value plus ramp down value; OFF TIME value should be set for more
than ON TIME value. For example, if you set on ramp value for 2
seconds, ON TIME should be set for more than 4 seconds (2+2), and
OFF TIME should be set for more than 4 seconds.
i.e. ON TIME > = Ramp up + Ramp down
OFF TIME > = ON TIME
Symmetric (S)
The pulse of CHANNEL 1 and CHANNEL 2 are synchronous. While
Channel 1 is activated, Channel 2 will be activated simultaneously. The
pulses active and inactive duration is controlled by ON TIME and OFF
TIME. In this mode, ON TIME value should be set for more than ramp
up value plus ramp down value. For example, if you set on ramp value
for 2 seconds, ON TIME should be set for more than 4 seconds (2+2).
i.e. ON TIME > = Ramp up + Ramp Down

INTRODUCTIONS FOR USE (NOTE: Always read this instruction manual before use.)

PREPARATION FOR USE
4.1 Check Battery:

Proceed to insert a fresh 9V alkaline or rechargeable battery
into the battery compartment. Make sure that you are
installing the batteries properly. The battery is inserted in the
casing on the back of the stimulator unit. BE SURE TO
MATCH THE POSITIVE AND NEGATIVE ENDS OF
THE BATTERY TO THE MARKINGS IN THE BATTERY
COMPARTMENT OF UNIT. To remove the batter cover,
press and tug it following the direction of the arrow indicated
on the battery cover:

Note: Please install batteries according to their positive (+)
and negative (-) ends correctly




CONNECTING THE STIMULATOR
4.2 Connect electrodes to lead wires:
Insert the lead wire connector into electrodes connector
(standard 0.08 inch female connection).
MAKE SURE THAT NO BARE METAL OF THE
PINS IS EXPOSED.



Caution:
1.
Always use electrodes whose measure of area is more than 16 cm
2
2. Always use electrodes which fulfilled local regulatory requirement.

4.3 Connect Lead Wires to Unit:
Before proceeding to this step, be sure the unit is completely turn OFF. Holding the insulated
portion of the lead wire connector, insert the angled L plug into the receptacle on the top of the
main unit. Please ensure the lead wires are inserted correctly.

The unit has tow output receptacles which are controlled by Channel 1 and Channel 2 Amplitude
Control knobs at the top of the unit. You may choose to use one channel with one pairs of lead
wires or both channels with 2 pairs of lead wires. Using both channels gives the user the
advantage of stimulating two different areas at the same time.


4.4 Place electrodes on skin:
Apply electrodes to the exact site indicated by your
physician following the instruction included with the
electrodes labeling. Make sure that the electrodes are placed
firmly to skin and make good contact between the skin and
the electrodes. Before applying electrodes, be sure that the
applied skin surface is thoroughly cleaned and dried. Place
the electrodes over the skin, attach them properly, firmly
and evenly.

4.5 Adjust Output:
Turn Amplitude Control knob for Channel 1 or Channel 2
clockwise. Then you will hear a BI! sound. Before you increase
the Amplitude, you must select the mode, rate and width.

Caution: If the stimulation levels are uncomfortable or become
uncomfortable, reduce the stimulation intensity to a comfortable
level and contact your physician if problems persist.

4.6 Select the Mode:
Press MODE button to set the stimulation mode recommended
by your physician or therapist. For details about stimulating
waveform and sequences, please refer to Sec.3 Stimulation
Modes Descriptions


Caution: Please consult physicians for your suitable stimulation mode.

OPERATION PROCEDURE CHART:
















4.7 Adjust the Ramp Time: (only in EMS function)
Form 1 second to 8 second, the stimulator special circuitry is designed so the electrical impulses
gradually build to a peak and then level off. This Ramped pulse produces a gradual muscle
contraction emulating natural muscle movement. It can also prevent spastic patients from reacting
adversely.
Press SET button to enter the ramp setting mode, then press INCREASE or DECREASE button to
adjust Ramp Time to the setting recommended by your medical professional.

4.8 Adjust Contraction (ON) Time: (only in EMS Function)
From 2 seconds to 99 seconds, press SET button to enter ON Time setting mode, then press
INCREASE or DECREASE button to adjust On Time to the setting recommended by your
medical professional.

4.9 Adjust Relaxation (OFF) Time: (only in EMS Function)
Fro 2 seconds to 99 seconds, press SET button to enter the OFF Time setting mode, then press
INCREASE or DECREASE button to adjust OFF Time to the setting recommended by your
medical professional. In order to prevent the spasticity, the Relaxation Time cant be adjusted less
than the contraction Time.

4.10 Adjust the Pulse Rate:
The pulses rate are adjustable 2~150 Hz, 2 Hz ~20 Hz in 1 Hz
increment and 20~150Hz in 5 Hz increment. Press SET button
to enter Pulse Rate set function, then press INCREASE or
DECREASE button to adjust Pulse Rate to setting recommended
by your medical professional.

4.11 Adjust the Pulse Width:
The pulse width is adjustable 50~300s in 10s increment.
Press SET button to enter the Pulse Width set function, then press INCREASE OR DECREASE
button to adjust pulse width to the setting recommended by your medical professional.
















4.12 Adjust Timer:
The timer is adjustable 5~90 minutes or continuous in 5 minutes
increment. Continuous option is just the next step to 90 minutes, i.e.
from 5-90 minutes to continuous and then to 5 minutes is a
cycle.During 5 minutes final count down, the clock symbol will
flash once every on second.

4.13 Adjust Channel Amplitude:
Turn Channel 1 or 2 clockwise. The output indication will be showed on the left side (Channel 1)
and right side (Channel 2) of the LCD screen as long as the unit is in operation. Slowly turn the
Channel Amplitude control until you reach the setting recommended by your medical professional.
Repeat for the other channel, if both channels are to be used.

Caution: if the stimulation levels are uncomfortable or become uncomfortable, reduce the
stimulation intensity to a comfortable level and contact your physician if problems persist.

4.14 Turn Unit Off:
Turn both channel controls to OFF. Then unplug the electrode lead wires, grasping them by the
plug, not the cord. If treatment will be resumed shortly the electrodes may be left on the skin.
When the electrodes are removed, clean the skin and the electrodes thoroughly with mild soap and
water. If there is skin irritation , consult your medical professional.

Caution: When the therapy time is complete, if the user doesnt turn off the amplitude know,
the unit will have Bi-Bi sound every 10 seconds until the amplitude know is turn off
completely.

4.15 Patient Compliance Time:
The patient compliance timer can memorize 60 sets of operation records; the total record time is
999 hours.

After the unit is turned off, you can start to use patient compliance timer. First, press and hold
Mode button and turn on the either one amplitude knob simultaneously to initiate patient
compliance timer.

Individual Treatment Time:
Press INCREASE button (triangle button) or DECREASE
button (inverted triangle button) to see next record of treatment
time with the number of times or previous record of treatment
time with the number of times.

Press and hold SET button for 3 seconds to delete the on
showing record. After the on showing record is deleted, the unit
will sound Bi!

Note:
1. If the treatment time is under one minute, it will not be recorded. For example, if your
treatment time is 10 minutes and 30 seconds, the patient compliance timer will record 10
minutes, not 11 minutes.
2. The patient compliance timer can only record up to 999 minutes for each treatment.
Therefore, if you keep using the stimulator for over 999 minutes, it will only record 999
minutes and the record time will flash to mean the treatment time is over 999 minutes.

Cumulative Treatment Time
When initiating patient compliance timer, press MODE to
shift the record of individual treatment time with the number
of times to the record of cumulative treatment time. When
showing the record of cumulative treatment time, there will be
an M mark flashing on the upper right corner of middle-
right screen.

Press and hold MODE & SET button simultaneously for 3 seconds to delete all the records
including individual treatment time record and cumulative treatment time record.

The patient compliance timer will keep the records even when the battery has no charge.
Only when users press and hold SET or MODE, and SET, the records will be deleted.

CARE AND MAINTENANCE
4.16 Portability:
Your unit is portable and may be clipped to a belt, shirt pocket, bra
or other clothing.

4.17 Low Battery Indicator:
When the lower power indicator flashes, it means that the battery should be
replaced with a new one as soon as possible. However, the stimulator will
continue to operate for several more hours.

4.18 Battery:
To replace the battery, remove the battery cover and extract the
battery. Replace it with a 9 V alkaline or similar rechargeable
battery. Notice that the battery is inserted correctly.




4.19 Care of Electrodes:
To avoid skin irritation and ensure good contact with skin, clean
silicone rubber electrodes withy soap and water frequently. The
electrodes must be dried completely before using.
If you are using self-adhesive electrodes, please disregard this
procedure.
The user shall always use the electrodes which fulfill the local
regulatory requirements.

4.20 Care of Electrode Cords:
Clean the electrodes cords by wiping them with damp cloth.
Coating them lightly with talcumpowder will reduce tangles and
prolong the life.

HANDLING AND STORAGE
Keep this device into the handy carrying case and storage at room temperature.

SPECIFICATION
Channel: Dual, isolated between channels
Power Source:
9V DC square shape battery (alkaline batteries or similar
rechargeable cell)
Output Waveform: Asymmetric biphasic square pulse.
Pulse Width: Variable, 50~300s
Pulse Frequency: Variable, 2~150Hz
Adjustable
Intensity Levels:
0 to 40 Volts(at load=500ohm)
Patient
Compliance
Timer:
Memorize 60 sets of operation records. Total record time is 999
hours.
TENS
Burst, Normal, MRW(Modulated Rate & Width), SD
(Strength Duration), Bi-Pulse Modes:
EMS Asymmetric, Symmeytric
Operation
Ambient:
Temperature range:10C~35C
Humidity range: 20~90% RH
Storage &
Transportation:
Temperature range: 10C~70C
Humidity range: 20~90% RH
Timer 5~90 minutes auto-shutoff or Continuous
Lead Wires: Male connector 2.0 +- 0.1
Safety Standard:
IEC 60601-1, IEC 60601-1-2(EMC Test), IEC 60601-2-10 (partly
applied)

All values have +- 10% tolerance.



TROUBLESHOOTING
The LCD indicator lights up
but unit does not function
properly.
Low Battery indicator flash.
None of LCD indicators
lights up
1. Check all control
settings. Are they set to
values prescribed by your
medical professional?
2. Are electrodes in proper
position?
3. Check lead wires. Be
sure all connectors are
firmly sealed.
4. Replace cord set with
another to check for
broken wires.
1. Replace battery with a new
one.
1. Replace battery with
a new one.